21 CFR Part 226 · Current Good Manufacturing Practice for Type a Medicated Articles

§ 226.42 Components

Subpart C - Product Quality Control Official text on eCFR Amendment history

(a) Drug components, including undiluted drugs and any intermediate mixes containing drugs used in the manufacture and processing of Type A medicated article(s), shall be received, examined or tested, stored, handled, and otherwise controlled in a manner to maintain the integrity and identification of such articles. Appropriate receipt and inventory records shall be maintained for 2 years, and such records shall show the origin of any drug components, the manufacturer's control number (if any), the dates and batches in which they were used, and the results of any testing of them.

(b) Nondrug components shall be stored and otherwise handled in a manner to avoid contamination, including cross-contamination from manufacturing operations.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 226.42

Form FDA 483 observations citing this section, fiscal years 2009–2025 (Veterinary Medicine).

  • Components receiving, testing, handling, et. al. 6

Amendment history

Federal Register documents that created or amended this section.